FDA 510(k) Application Details - K200606

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K200606
Device Name	Syringe, Piston
Applicant	Orthofix, Inc. 3451 Plano Parkway Lewisville, TX 75056 US Other 510(k) Applications for this Company
Contact	Troy Brooks Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/09/2020
Decision Date	05/01/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review